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pp-093

Injection

Dossier type
CTD
Dossier status
Under development
Country of origin
Japan
Comments
Indication: Passive fecal incontinence caused by impaired internal anal sphincter function, characterized by involuntary stool loss without preceding urge; intended for patients insufficiently managed by dietary modification, biofeedback, medication, neuromodulation, or artificial sphincter implantation. Clinical stage: Development program in progress; preclinical validation of smooth-muscle–directed regenerative cell therapy; differentiation technology demonstrated in vitro and in vivo; patent pending. Modality: Autologous cell therapy. Mechanism / Target: Differentiation of precursor skeletal-muscle–derived cells into smooth muscle cells, followed by local injection to regenerate the internal anal sphincter and restore continence function by addressing the underlying cause rather than symptoms. Route / form: Local injection into the internal anal sphincter region. Differentiation: First regenerative cell therapy candidate specifically targeting the smooth muscle of the internal anal sphincter; addresses a major unmet need in passive fecal incontinence where existing therapies are inadequate or highly invasive; leverages proprietary differentiation technology enabling generation of smooth muscle cells from accessible skeletal muscle biopsies.
Manufacturer #38642

A clinical-stage biotechnology firm developing regenerative cell therapies to treat fecal and urinary incontinence by restoring sphincter muscle function rather than just managing symptoms. It advances proprietary autologous cell therapy programs through multinational Phase III clinical development with global strategic aims. The organization combines R&D, manufacturing and clinical expertise to address high unmet needs.

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